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001 ocn162571734
003 OCoLC
005 20160527041009.3
006 m o d
007 cr cn|||||||||
008 070806s2006 mau ob 001 0 eng d
019 76697795|a85766756|a441762043|a505064176|a647545036
|a701878860|a814467746|a823136810|a843151739
020 9780122107511
020 0122107519
020 0080454208|q(electronic book)
020 9780080454207|q(electronic book)
020 1280633417
020 9781280633416
024 3 |z9780122107511
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|z(OCoLC)701878860|z(OCoLC)814467746|z(OCoLC)823136810
|z(OCoLC)843151739
037 90127:90127|bElsevier Science & Technology|nhttp://
www.sciencedirect.com
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049 RIDW
050 4 R853.P75|bD47 2006eb
072 7 HEA|x032000|2bisacsh
072 7 MED|x034000|2bisacsh
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082 04 615.50724|222
090 R853.P75|bD47 2006eb
100 1 DeRenzo, Evan G.|0https://id.loc.gov/authorities/names/
no2005091250
245 10 Writing clinical research protocols :|bethical
considerations /|cEvan G. DeRenzo and Joel Moss.
264 1 Burlington, MA ;|aLondon :|bElsevier Academic,|c[2006]
264 4 |c©2006
300 1 online resource (xix, 300 pages)
336 text|btxt|2rdacontent
337 computer|bc|2rdamedia
338 online resource|bcr|2rdacarrier
340 |gpolychrome|2rdacc
347 text file|2rdaft
504 Includes bibliographical references and index.
505 0 Introduction to the art and science of clinical research -
- What you need to know about clinical research ethics --
What you need to know about the regulation of clinical
research -- Designing a clinical research study --
Selecting subjects for clinical studies -- Risks and
benefits in clinical research -- Recruiting subjects --
Informed consent -- Privacy and confidentiality -- The
"ethics" section -- Procedures and methods -- Statistics,
data collection and management, and record keeping -- Use
of human biological materials -- Special issues raised by
evolving areas of clinical research -- Case histories :
learning from experience.
505 0 What You Need To Know About Research Ethics Before
Deciding on What You Want To Study -- Designing a Clinical
Research Study -- Writing Consent and Assent Documents --
Getting the Protocol Approved -- Conducting the Study;
Special Populations -- Ethical Considerations in Genetics
Research -- Ethical Considerations in Use of Tissue for
Laboratory Investigations -- Ethical Considerations in Use
of Stored Tissue -- Confidentiality Issues -- Research in
Emergency Medicine -- Reporting of Adverse Events -- FDA -
- Radiation Safety Issues -- Participation of Subjects in
Multi-Site Trials -- Participation of Subjects in Multiple
Studies -- Conduct of Pharmaceutical Industry Research --
Case Histories, Learning from Experience -- Appendix.
520 This highly engaging guide for clinical researchers
provides a foundation for improving skills in the
understanding of ethical requirements in the design and
conduct of clinical research. It includes practical
information on ethical principles in clinical research,
designing appropriate research studies, writing consent
and assent documents, getting protocols approved, special
populations, confidentiality issues, and the reporting of
adverse events. A valuable appendix includes a listing of
web resources about research ethics as well as a glossary.
This will be an invaluable resource for basic scientists
collaborating in clinical trials, physician investigators,
clinical research fellows, research nurse coordinators,
residents, and anyone who wants a better understanding of
the clinical trials process. * Walks investigators and
trainees through identification of the ethical aspects of
each section of a clinical research protocol * Includes a
chapter containing Case Histories * Contains information
on conducting clinical research within the pharmaceutical
industry * An appendix includes internet resources and
world wide web addresses for important research ethics
documents and regulations * Chapter on 'Study Design and
Methodology' purposely expanded to explicitly address
biostatistical considerations.
588 0 Print version record.
590 eBooks on EBSCOhost|bEBSCO eBook Subscription Academic
Collection - North America
650 0 Clinical trials.|0https://id.loc.gov/authorities/subjects/
sh85027069
650 2 Clinical Protocols.|0https://id.nlm.nih.gov/mesh/D002985
650 2 Ethics.|0https://id.nlm.nih.gov/mesh/D004989
650 2 Writing.|0https://id.nlm.nih.gov/mesh/D014956
650 7 Clinical trials.|2fast|0https://id.worldcat.org/fast/
864429
655 4 Electronic books.
700 1 Moss, Joel.|0https://id.loc.gov/authorities/names/
n85031249
776 08 |iPrint version:|aDeRenzo, Evan G.|tWriting clinical
research protocols.|dBurlington, MA ; London : Elsevier
Academic, ©2006|z9780122107511|z0122107519
|w(OCoLC)56453025
856 40 |uhttps://rider.idm.oclc.org/login?url=http://
search.ebscohost.com/login.aspx?direct=true&scope=site&
db=nlebk&AN=166146|zOnline eBook. Access restricted to
current Rider University students, faculty, and staff.
856 42 |3Instructions for reading/downloading this eBook|uhttp://
guides.rider.edu/ebooks/ebsco
901 MARCIVE 20231220
948 |d20160615|cEBSCO|tebscoebooksacademic|lridw
994 92|bRID
